The present invention relates to a test kit for the collection and testing of urine samples for drugs of abuse and subsequent shipment of the sample, more particularly, to such a test kit for low volumes of urine samples and having a transparent envelope-type container and a test card for indicating visually the presence of particular drugs of abuse.
The increased availability and use of drugs of abuse by the general population has caused employers, governmental agencies, sports groups and other organizations to utilize drug screening both as a condition of employment and in order to maintain safety in the work place. Urine-based screening tests for the detection of drugs of abuse range in complexity from simple immunoassay tests to very complex analytical procedures. Over the years the speed and specificity of immunoassays have made them one of the most accepted methods for screening for drugs of abuse in urine. Typical drug screening tests are performed for the purpose of quickly identifying on a qualitative basis the presence of drugs in a body fluid which may be urine. A complete analysis of the sample may then be carried out in a laboratory only if the preliminary screening results are positive. More and more such drug screenings are taking place on site or the work place and are generally carried out by testing personnel who are generally not technically trained, such as laboratory technicians. It is thus important that the drug screening procedure is simple but yet reliable. Further, the test apparatus must be such so as to enable the testing personnel to avoid all contact with the fluid specimen which is being tested.
Various forms of devices had been proposed for the collection and taking of body fluids, such as urine, which have proved to be cumbersome in operating since they involve a number of separate steps. Initially, the sample was collected and several additional steps were then required to transfer the urine sample to an analysis device. This multiple step procedure required the manual handling of the specimen through various devices and the use of such transfer devices inevitably caused spills which may result in contamination to the tester and surroundings. In addition, nontechnical personnel who perform the screening tests on urine samples objected to coming into any kind of contact with the urine sample and even the handling of the sample itself.
Many of the known testing devices were rather complex in that they included a container for the specimen, and, subsequently it was necessary to transfer the specimen or at least a portion thereof to another compartment of the container in order to perform the test. This transfer of the specimen required vigorous shaking of the container or turning the container upside down in order to cause the flow of the specimen into a test compartment. It was therefore necessary to make the containers leak proof under such condition and the result was a complicated and expensive container structure.
Further, the containers incorporated the structure by means of which reagent strips were mounted in a test compartment of the container and which structure also enabled the fluid sample to flow into the test compartment into contact with the reagent strips. Such a mounting of the reagent strips further resulted in complicating the structure of the container since it was also necessary that provision be made to view the reagent strips from outside of the container. This was generally achieved by providing a transparent window or some other mounting of the reagent strips so that they are visible to testing personnel.
Generally, cylindrical or cup-like containers, usually made of a thermoplastic material, are used. However, the volume of such containers requires a urine sample of the order of 15 ml. which under some circumstances may not be available. In the drug testing of infants or persons who are admitted under emergency conditions to a hospital or clinic, only a bare minimum of a urine sample may be available and this bare minimum would not be sufficient to conduct a drug abuse test with the usual cup-like container. For the drug testing of such persons, for infants, resort may be had to wringing the diapers to obtain a few drops of urine therefrom and even in the case of seriously injured persons, a few drops of a urine sample might be available from the clothing.
It is therefore the principal object of the present invention to provide a simplified and inexpensive device for the collection and testing of low volumes of body fluid samples, particularly urine, for drugs of abuse and subsequent shipment of the sample.
It is an additional object of the present invention to provide a drug test kit which includes a flat envelope or bag container for retaining a urine sample having such a closure structure that when a test card having a plurality of test strips is introduced into the container, the test strips will contact the urine sample.
It is a further object of the present invention to provide a test card having a plurality of immunoassay test strips thereon with each strip being responsive to a particular drug of abuse and having a visual endpoint to indicate the presence or absence of a particular drug.
It is another object of the present invention to provide a novel and improved process for the testing of low volumes of a fluid sample for drugs of abuse using a test card having a plurality of immunoassay test strips thereon.
The objects of the present invention are achieved and the disadvantages of the prior art are eliminated by the drug abuse test device according to the present invention which may comprise a flat envelope or bag transparent container for retaining a urine sample to be tested. The open top of the container is of such a size to accommodate a test card which has a plurality of immunoassay test strips mounted thereon in parallel on one or both sides and each test strip is responsive to a particular drug of abuse. The test card is insertable through the open top or end so as to have one end immersed in the urine sample to a predetermined depth whereby the visual results of each test strip can be seen through the transparent or translucent wall of the container without removing the test card from the container so as to indicate the presence or absence of a particular drug of abuse in the urine sample. If the sample should test xe2x80x9cpositivexe2x80x9d to indicate the presence of a drug in the urine, it is then necessary to send the sample to a certified laboratory for confirmatory testing.
As described above, the test kit includes a drug abuse test device for collecting and testing a urine sample. This test device comprises a flat envelope or bag preferably having a transparent wall and having an open top or end in the shape of a slit therein to receive a test card.
This new test kit would thus test as little as 2.0 ml. of urine or any other fluid sample as compared with the usual 30-48 ml. such as when a test cup is used. This test kit incorporates a particular structure of a container rather than the usual test cup. This ability to test lower volumes is ideal for use in hospital and clinical settings as well for compliance with laboratory certification and quality control requirements.
The test kit also includes a test card for drugs of abuse which may comprise a thin flat member having the size and shape of a business card. A plurality of immunoassay test strips are fastened side by side in parallel on one side of the test card within the outline of the card. Each test strip is reactive to provide a visual indication in response to a particular drug of abuse. This test card thus provides for the simultaneous detection of multiple analytes.